Some Regulators get it, Start-ups are different… Please see the Concierge…

19 March 2013 |

For a start-up, regulatory affairs becomes just one of many competing demands for time and resources – and all too often it’s put off until too late.

Some regulators get it – and are establishing offices or portals specifically designed to help small businesses deal with the complexities of regulatory affairs and get some early advice.  Singapore HSA in streamlining its medical devices premarket process included a Small Manufacturers “concierge service”.

Now the UK MHRA has opened its “Office of Innovation”  and announced it with an eye catching YouTube video.

Of course regulatory is not the paperwork at the end of product development.  Medical device regulation is all about control of the development process – so leaving it to the end all too often leads to unpleasant surprises, retesting or ruinously expensive last minute redesign.  Design control failures are still a leading cause of FDA Warning letters.

A start up needs to understand the requirements, applicable standards and the costs on day one to be able to plan effectively and to live and breathe compliance as part of the development process.

Need help with a regulatory plan? Go view the MHRA video, ask some questions on their confidential enquiry service, then – let’s talk…

Help button-Quick Call-Brandwood BiomedicalNeed assistance with biological evaluation and testing?  We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.

Contact us to discuss your needs and how we can help. You can drop us an Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)


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